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VASOTEC Drug Profile

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Which patents cover Vasotec, and what generic alternatives are available?

Vasotec is a drug marketed by Biovail Labs Intl and Bausch and is included in two NDAs.

The generic ingredient in VASOTEC is enalapril maleate. There are twenty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.

US ANDA Litigation and Generic Entry Outlook for Vasotec

A generic version of VASOTEC was approved as enalapril maleate by HERITAGE PHARMA on January 25^th, 2020.

Summary for VASOTEC

US Patents:	0
Applicants:	2
NDAs:	2
Suppliers / Packagers:	10
Bulk Api Vendors:	97
Clinical Trials:	6
Patent Applications:	5,805
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VASOTEC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VASOTEC
DailyMed Link:	VASOTEC at DailyMed

See drug prices for VASOTEC

See drug sales revenues for VASOTEC

Recent Clinical Trials for VASOTEC

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Brigham and Women's Hospital	Phase 4
Novartis Pharmaceuticals	Phase 4
University of Wisconsin, Madison	Phase 4

See all VASOTEC clinical trials

Recent Litigation for VASOTEC

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Apotex, Inc. v. Mylan Pharmaceuticals, Inc.	2012-04-20
Apotex, Inc. v. UCB, Inc.	2012-04-20

See all VASOTEC litigation

Pharmacology for VASOTEC

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors
Physiological Effect	Decreased Blood Pressure

Synonyms for VASOTEC

((S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl)-L-alanyl-L-proline

(2S)-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic aci

(2S)-1-[(2S)-2-[[(1S)-1-ethoxycarbonyl-3-phenyl-propyl]amino]propanoyl]pyrrolidine-2-carboxylic acid; maleic acid

(2S)-1-[(2S)-2-[[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino]propanoyl]pyrrolidine-2-carboxylic acid

(2S)-1-[(2S)-2-{[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino}propanoyl]pyrrolidine-2-carboxylic acid

(S,S,S)-1-[2-(1-Ethoxycarbonyl-3-phenyl-propylamino)-propionyl]-pyrrolidine-2-carboxylic acid

(S,S,S)-Enalapril Maleate

(S)-(-)-1-[N-(1-Ethoxycarbonyl-3-phenylpropyl)-L-alanyl]-Lproline

(S)-1-((S)-2-((R)-1-ethoxy-1-oxo-4-phenylbutan-2-ylamino)propanoyl)pyrrolidine-2-carboxylic acid

(S)-1-(N-(1-(Ethoxycarbonyl)-3-phenylpropyl)-L-alanyl)-L-proline

(S)-1-(N-(1-(Ethoxycarbonyl)-3-phenylpropyl)-L-alanyl)-L-proline maleate

(S)-1-(N-(1-(Ethoxycarbonyl)-3-phenylpropyl)-L-alanyl)-L-proline maleate (1:1)

(S)-1-[(R)-2-((R)-1-Ethoxycarbonyl-3-phenyl-propylamino)-propionyl]-pyrrolidine-2-carboxylic acid

(S)-1-[N-[1-(ETHOXYCARBONXYL)-3-PHENYLPROPYL]-L-AL

(S)-1-[N-[1-(ETHOXYCARBONYL)-3-PHENYLPROPYL]-L-ALANYL]-L-PROLINE MALEATE

(S)-1-{(S)-2-[1-((S)-Ethoxycarbonyl)-3-phenyl-propylamino]-propionyl}-pyrrolidine-2-carboxylic acid

(S)-N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-Ala-Pro maleate salt

(SSS)1-[2-(1-Ethoxycarbonyl-3-phenyl-propylamino)-propionyl]-pyrrolidine-2-carboxylic acid

(Z)-but-2-enedioic acid; (2S)-1-[(2S)-2-[[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino]propanoyl]pyrrolidine-2-carboxylic acid

(Z)-but-2-enedioic acid;(2S)-1-[(2S)-2-[[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino]propanoyl]pyrrolidine-2-carboxylic acid

095E164

1-(N-((S)-1-Carboxy-3-phenylpropyl)-L-alanyl)-L-proline 1'-ethyl ester

1-(N-((S)-1-Carboxy-3-phenylpropyl)-L-alanyl)-L-proline 1'-ethyl ester, maleate (1:1)

1-[2-(1-Ethoxycarbonyl-3-phenyl-propylamino)-propionyl]-pyrrolidine-2-carboxylic acid

1-[2-(1-Ethoxycarbonyl-3-phenyl-propylamino)-propionyl]-pyrrolidine-2-carboxylic acid (Enalapril)

1-[2-(1-Ethoxycarbonyl-3-phenyl-propylamino)-propionyl]-pyrrolidine-2-carboxylic acid(enalapril)

1-[N-[(S)-1-Ethoxycarbonyl-3-phenylpropyl]-L-alanyl]-L-proline Maleate

172964-46-4

2-[2-(1-Carboxy-3-phenyl-propylamino)-propionyl]-1,2,3,4-tetrahydro-isoquinoline-3-carboxylic acid(enalapril)

69PN84IO1A

75847-73-3

75847-73-3 (Parent)

76095-16-4

76095-16-4 (maleate)

76420-75-2

77549-58-7

77549-59-8

847E733

9O25354EPJ

A-Rin

AB00053615_19

AB00053615_20

AB00053615-17

AB00053615-18

AB0013100

AB2000386

AC1NTUS2

AC1NTUS5

Acetensil

AKOS016340376

AKOS025310615

Alphrin

Amprace

AN-15422

analapril

Analept

AOB5651

API0002541

Atens

Baripril

BDBM50017129

Benalapril

Benalipril

BIDD:GT0751

Biocronil

BPBio1_000340

BQL

BRD-K57545991-050-16-5

BSPBio_000308

BSPBio_003035

C-21264

C06977

C20H28N2O5

C20H28N2O5.C4H4O4

CAS-75847-73-3

CAS-76095-16-4

CC-27456

CCG-39221

CHEBI:4784

CHEBI:4785

CHEMBL1200659

CHEMBL578

Controlvas

Converten

Convertin

Coprilor

Coroldil

CPD001906771

Crinoren

CS-2373

CS-2918

CTK8F9436

D00621

D07892

Dabonal

DB00584

Defluin

Denapril

Ditensor

DivK1c_000408

DSSTox_CID_2982

DSSTox_GSID_22982

DSSTox_RID_76817

DTXSID5022982

Ecapril

Ednit

Ednyt

EINECS 278-375-7

EINECS 278-460-9

Elfonal

Enacard

Enalabene

Enaladex

Enaladil

enalapril

Enalapril (INN)

Enalapril (maleate)

Enalapril (TN)

Enalapril [INN:BAN]

enalapril hydrogen maleate

Enalapril maleate

Enalapril maleate (JP17/USP)

Enalapril maleate (Vasotec)

Enalapril maleate [USAN:JAN]

Enalapril maleate [USAN:USP:JAN]

Enalapril maleate salt

Enalapril Maleate Usp Xxi

Enalapril Richet

Enalapril, AldrichCPR

Enalaprila

Enalaprila [INN-Spanish]

Enalaprilmaleate

Enalaprilum

Enalaprilum [INN-Latin]

Enalasyn

Enaloc

Enalped

Enap

Enapren

Enapres

Enapril

Enaprin

Enarenal

Enaril

Envas

Epaned

Epaned Kit

Eupressin

Feliberal

GBXSMTUPTTWBMN-XIRDDKMYSA-N

Glioten

Glioten;Renitec;Vasotec

GTPL6322

H531

Herten

Hipoartel

Hipten

HMS1921B10

HMS2090E08

HMS2092L17

HMS2095P10

HMS2231D22

HMS2232I24

HMS3712P10

HMS501E10

HSDB 6529

HY-B0331

HY-B0331A

Hytrol

I04-153

IDI1_000408

Innovace

Innovace Melt

Innovade

Inoprilat

Insup

Invoril

J10412

K298

KBio1_000408

KBio2_001787

KBio2_004355

KBio2_006923

KBio3_002535

KBioGR_000355

KBioSS_001787

Kenopril

KM1738

Konveril

KS-1137

L-Proline, 1-(N-(1-(ethoxycarbonyl)-3-phenylpropyl)-L-alanyl)-, (S)-

L-Proline, 1-(N-(1-(ethoxycarbonyl)-3-phenylpropyl)-L-alanyl)-, (S)-, (Z)-2-butenedioate (1:1)

L-Proline, N-((1S)-1-(ethoxycarbonyl)-3-phenylpropyl)-L-alanyl-

L-Proline, N-((1S)-1-(ethoxycarbonyl)-3-phenylpropyl)-L-alanyl-, (2Z)-2-butenedioate (1:1)

L-Proline, N-[(1S)-1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl-

Lapril

Lipraken

Lotrial

LS-118938

LS-190651

Mapryl

Mepril

MFCD00133304

MFCD00865774

Minipril

MK 421

MK 421 maleate

MK-421

MLS000028657

MLS001077272

MLS006010047

MolPort-002-885-877

MolPort-003-666-389

N-((S)-1-Ethoxycarbonyl-3-phenylpropyl)-L-alanyl-L-proline maleate (1:1)

N-(1 (S)-ethoxycarbonyl-3-phenylpropyl)-L-alanyl-L-proline maleate

N-(1(S)-Ethoxycarbonyl-3-phenylpropyl)-L-alanyl-L-proline

N-(1(S)-ethoxycarbonyl-3-phenylpropyl)-L-alanyl-L-proline maleate

N-[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]-L-alanyl-L-proline

N-[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]-L-alanyl-L-proline (2Z)-but-2-enedioate

N-[1-(S)-ethoxycarbonyl-3-phenylpropyl]-L-alanyl-L-proline

N-[1(S)-Ethoxycarbonyl-3-phenylpropyl]-L-alanyl-L-proline maleic acid salt

N-{(1S)-1-[(ethyloxy)carbonyl]-3-phenylpropyl}-L-alanyl-L-proline

N-{N-[(S)-1-ethoxycarbonyl-3-phenylpropyl]-L-alanyl}-L-proline hydrogen maleate

Nalpha -[(S)-1-ethoxycarbonyl-3-phenylpropyl]-L-alanyl-L-proline

Naprilene

Naritec

NCGC00016932-01

NCGC00021569-04

NCGC00021569-05

NCGC00021569-06

NCGC00021569-09

Neotensin

NINDS_000408

Norpril

NSC-758143

NSC758143

Nuril

Opera_ID_1793

OYFJQPXVCSSHAI-QFPUQLAESA-N

Palane

Pharmakon1600-01501214

Pres

Presil

Pressotec

Prestwick_197

Prestwick3_000314

Pril

Prilenap

PRO106

Pulsol

Reca

Regomed

Renavace

Renitec

Reniten

Renivace

Renivace (TN)

Repantril

Ristalen

s1941

SAM002564252

SBI-0051691.P002

SC-17520

SC-76440

SCHEMBL18

SCHEMBL9

Sintec

SMR000058883

SMR000653477

SPBio_001349

Spectrum_001307

SPECTRUM1501214

Spectrum2_001455

Spectrum3_001478

Spectrum4_000008

Spectrum5_001107

SR-01000000234

SR-01000000234-4

SR-05000001785

SR-05000001785-1

SW198780-2

Tenace

Tensazol

Tox21_110872

Tox21_110872_1

Unaril

UNII-69PN84IO1A

UNII-9O25354EPJ

Vapresan

Vasopril

Xanef

ZINC3791297

Paragraph IV (Patent) Challenges for VASOTEC

Tradename	Dosage	Ingredient	NDA	Submissiondate
VASOTEC	TABLET;ORAL	enalapril maleate	018998

US Patents and Regulatory Information for VASOTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biovail Labs Intl	VASOTEC	enalaprilat	INJECTABLE;INJECTION	019309-001	Feb 9, 1988		DISCN	Yes	No
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-002	Dec 24, 1985	AB	RX	Yes	No
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-005	Jul 26, 1988	AB	RX	Yes	No
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-001	Dec 24, 1985	AB	RX	Yes	No
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-003	Dec 24, 1985	AB	RX	Yes	Yes

Expired US Patents for VASOTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biovail Labs Intl	VASOTEC	enalaprilat	INJECTABLE;INJECTION	019309-001	Feb 9, 1988
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-003	Dec 24, 1985
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-005	Jul 26, 1988
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-001	Dec 24, 1985
Bausch	VASOTEC	enalapril maleate	TABLET;ORAL	018998-002	Dec 24, 1985